TELO US Equity☆

UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

D.C. 20549

Form

10-K

For

the fiscal year ended December 31, 2024

For

the transition period from__________ to _________

Commission

file number 001-31361

Telomir

Pharmaceuticals, Inc.

(Exact

name of registrant as specified in its charter)

(Address of principal executive offices) (Zip Code)

Registrant’s

telephone number: 786-396-6723

Securities

registered pursuant to Section 12(b) of the Act:

Title of each class Trading Symbol(s) Name of exchange on which registered

Common stock, no par value TELO The Nasdaq Capital Market

Securities

registered pursuant to Section 12(g) of the Act: None

Indicate

by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

Indicate

by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒

Indicate

by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange

Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)

has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate

by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule

405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files)

Yes ☒ No ☐

Indicate

by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer or a smaller reporting

company. See definition of “large accelerated filer”, “accelerated filer” and “smaller reporting company”

in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer ☐ Accelerated filer ☐

Non-accelerated filer ☒ Smaller reporting company ☒

Emerging growth company ☒

If

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate

by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness

of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered

public accounting firm that prepared or issued its audit report. ☒

If

securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant

included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate

by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation

received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate

by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

The aggregate market value of the voting and non-voting common equity held

by non-affiliates as of June 30, 2024, was $113.3 million based on the closing sale price of the company’s common stock on

such date of $4.81 per share, as reported by the NASDAQ Capital Market

As

of February 4, 2025, there were 29,762,671 shares of company common stock issued and outstanding.

Telomir

Pharmaceuticals, Inc.

Annual

Report on Form 10-K

For

the fiscal year ended December 31, 2024

TABLE OF CONTENTS

Page

Cautionary Note on Forward-Looking Statements 3

PART I 4

Item 1. Description of Business 4

Item 1A. Risk Factors 19

Item 1B. Unresolved Staff Comments 46

Item 1C. Cybersecurity 46

Item 2. Description of Property 46

Item 3. Legal Proceedings 46

Item 4. Mine Safety Disclosure 46

Item 5. Market for Common Equity and Related Stockholder Matters 47

Item 6. [Reserved] 47

Item 7A. Quantitative and Qualitative Disclosures About Market Risk 54

Item 8. Financial Statements 54

Item 9A. Controls and Procedures 55

Item 9B. Other Information 55

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 55

PART III 55

Item 10. Directors, Executive Officers and Corporate Governance 55

Item 11. Executive Compensation 61

Item 14. Principal Accountant Fees and Services 72

Item 15. Exhibits, Financial Statement Schedules 73

Signatures 75

Unless

we have indicated otherwise, or the context otherwise requires, references in this Report to “TELO,” the “Company,”

“we,” “us” and “our” or similar terms refer to Telomir Pharmaceuticals, Inc., a Florida corporation.

From

time to time, we may use our website, our Facebook page at https://www.facebook.com/people/Telomir-Pharmaceuticals-Inc/100087267737318/#,

our Twitter at https://x.com/TelomirPharma, and on our LinkedIn account at https://www.linkedin.com/company/telomir-pharmaceuticals-inc/posts/?feedView=all

to distribute material information. Our financial and other material information is routinely posted to and accessible on the Investors

section of our website, available at www.telomirpharma.com. Investors are encouraged to review the Investors section of our website

because we may post material information on that site that is not otherwise disseminated by us. Information that is contained in and

can be accessed through our website, our Facebook page, our Twitter posts and our LinkedIn posts are not incorporated into, and does

not form a part of, this Annual Report.

CAUTIONARY

NOTE REGARDING FORWARD-LOOKING STATEMENTS

This

Annual Report on Form 10-K contains forward-looking statements (as defined in Section 27A of the

Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act) that

reflect our current expectations and views of future events. In some cases, you can identify forward-looking statements by terms

such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,”

“could,” “intend,” “target,” “project,” “contemplate,” “believe,”

“estimate,” “predict,” “potential”, or “continue” or the negative of these terms or other

similar expressions. In particular, statements about the markets in which we operate, including expectations regarding our studies, growth

of our various markets, and our expectations, beliefs, plans, strategies, objectives, prospects, assumptions, or future events or performance

contained in this Annual Report under the headings “Risk Factors,” “Management’s Discussion and Analysis of Financial

Condition and Results of Operations” and “Business” are forward-looking statements.

We

have based these forward-looking statements on our current expectations, assumptions, estimates and projections. While we believe these

expectations, assumptions, estimates, and projections are reasonable, such forward-looking statements are only predictions and involve

known and unknown risks and uncertainties, many of which are beyond our control. These and other important factors, including those discussed

in this Annual Report under the headings “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition

and Results of Operations” and “Business,” may cause our actual results, performance, or achievements to differ materially

from any future results, performance or achievements expressed or implied by these forward-looking statements, or could affect our share

price. Important factors that could cause actual results or events to differ materially and adversely from those expressed in forward-looking

statements include, but are not limited to, the following:

● the timing of anticipated regulatory filings;

● our future expenses, capital requirements and need for additional financing;

● our ability to recruit and enroll suitable patients in our clinical trials;

● developments relating to our competitors and our industry;

Given

the risks and uncertainties set forth in this Annual Report, you are cautioned not to place undue reliance on such forward-looking statements.

The forward-looking statements contained in this Annual Report are not guarantees of future performance and our actual results of operations,

financial condition, and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking

statements contained in this Annual Report. In addition, even if our results of operations, financial condition and liquidity, and events

in the industry in which we operate are consistent with the forward-looking statements contained in this Annual Report, they may not

be predictive of results or developments in future periods.

Any

forward-looking statement that we make in this Annual Report speaks only as of the date of such statement. Except as required by federal

securities laws, we do not undertake any obligation to update or revise, or to publicly announce any update or revision to, any of the

forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this Annual Report.

PART

I

ITEM

1. Description of Business

Overview

Telomir-1 is a novel oral small molecule metal

ion regulator designed to extend telomere caps, maintain cellular balance, and combat oxidative stress, a key driver of aging and disease

progression. By modulating essential metal ions such as iron, and copper, Telomir-1 may help protect against age-related conditions,

including Progeria (a rare genetic disorder that causes rapid aging in children), Wilson’s disease (a genetic disorder leading to

toxic copper buildup in the body), and Age-related Macular Degeneration (AMD), as well as Type 2 Diabetes, cancer, and Alzheimer’s

disease.

Oxidative stress also

plays a critical role in the propagation and severity of viral infections like bird flu, where the virus triggers an imbalance between increased production of reactive oxygen species (ROS) and reduced antioxidant

host responses that leads to increased redox stress, a process which ultimately excessive weakens

immune defenses, increases inflammation, and enables enhanced viral replication. By reversing oxidative stress, Telomir-1 may help

strengthen immune resilience and reduce disease severity, offering broad therapeutic potential across both age-related and

infectious diseases.

Telomeres

are repetitive DNA sequences at the end of chromosomes that protect the chromosomes from becoming frayed or tangled. Each time a cell

divides, the telomeres become slightly shorter, and eventually they become so short that the cell can no longer divide, with the result

being that the cell dies. Effectively, telomeres protect the ends of our chromosomes by forming a cap, much like the plastic tip on shoelaces,

thereby allowing the chromosome to be replaced properly during cell division. If demonstrated by future clinical trials and approved

by the U.S. Food and Drug Administration, or FDA, we believe Telomir-1 may protect variable cells by elongating and stimulating the telomeres

to sustain self-renewal and longevity.

Based on our preclinical studies, we have

gathered experimental evidence suggesting that Telomir-1 may act as a regulator of essential metal ions such as iron, zinc, and copper.

While these trace elements are critical for various physiological functions, imbalances—whether due to excess or deficiency—can

drive oxidative stress, leading to cellular damage, telomere shortening, and accelerated aging. This oxidative burden is also linked to

age-related conditions and certain cancers.

We believe Telomir-1 has the potential to protect cells in situ by mitigating

metal overload, particularly of iron and copper, which are known to accelerate oxidative stress and contribute to telomere attrition.

By modulating ion levels and reducing oxidative damage, Telomir-1 may help preserve telomere integrity, restore cellular homeostasis,

and enhance overall cell resilience, potentially slowing down age-related degeneration. Additionally, by reversing oxidative stress, Telomir-1

may help mitigate the severity of viral infections such as bird flu by strengthening cellular defense mechanisms and improving immune

system function, potentially reducing disease progression and severity.

Our

focus is on addressing the effects of iron and copper overload while emphasizing the protective role of zinc. Excess iron can cause serious

health problems, such as liver fibrosis, liver failure, heart issues, and endocrine dysfunction. It is also linked to type 2 diabetes

mellitus (T2DM), as it disrupts insulin secretion, increases insulin resistance, and affects glucose production in the liver. In the

retina, iron buildup leads to oxidative stress and damage, contributing to Age-related Macular Degeneration (AMD).

Copper,

while essential for many physiological processes, becomes harmful when present in excess. High levels of copper increase oxidative stress,

damage retinal cells, and disrupt mitochondrial energy production, which can result in cell death and tissue degeneration. Copper overload

is particularly significant in Wilson’s disease, a rare genetic disorder that causes toxic copper accumulation in vital organs

like the liver and brain, leading to severe health complications.

In

contrast, zinc plays a protective role by reducing oxidative stress, regulating iron and copper levels, and restoring balance in cases

of imbalance or deficiency. This highlights zinc’s critical role in maintaining physiological health and equilibrium.

Our

objective is to investigate the molecular mechanisms of action of Telomir-1 through various biochemical methods. Additionally, we utilize

a range of animal models to evaluate the drug’s therapeutic potential and activity. As our research advances and our understanding

deepens, we may consider exploring alternative indications or adjusting our focus based on emerging insights or evolving circumstances.

Telomir-1

is currently undergoing preclinical investigation, with the goal of submitting an Investigational New Drug (IND) application and an Investigational

New Animal Drug (INAD) application to the FDA. If accepted, these submissions would enable progression to human and animal clinical trials.

Our research focuses on Telomir-1’s potential to interrupt, regulate, and prevent inflammatory pathways and enzymatic intracellular

processes responsible for cellular metal imbalances. Preliminary studies suggest that Telomir-1 may achieve these outcomes by selectively

binding to and exchanging between metal ions in a form- and dose-dependent manner, slowing enzyme reactivity, and preserving cellular

functions. If clinical trials demonstrate its efficacy and it gains FDA and other regulatory approvals, we believe Telomir-1 could serve

as a non-toxic, orally administered ion-overload regulator with the potential to balance enzyme and pathway overactivity caused by excessive

metal reactivity.

To

date, we have completed multiple preclinical studies on Telomir-1, including those demonstrating that Telomir-1 is non-mutagenic and

possesses strong biological and metal-binding properties (Graphic 1). Using advanced “in silico modeling,” driven by artificial

intelligence to predict a compound’s therapeutic potential, chemical and biological activity, and toxicity, we continue to uncover

evidence supporting Telomir-1’s potential to address metal-overload conditions. Additionally, recent independent in vitro studies

have confirmed that Telomir-1 exhibits strong binding affinities for copper and iron, with reduced binding affinity for zinc.

Graphic

1: Telomir-1 is capable binding to several metal ions

We

collaborate with third-party organizations to conduct research and advance development efforts. One such partner, InSilico Trials, utilizes

in silico digital simulations to support drug development through computational modeling. These techniques allow us to efficiently predict

the safety and efficacy of potential compounds, reducing the need for extensive clinical trials. Additionally, we work with Recipharm

and Smart Assays to assess Telomir-1’s binding properties and investigate ion competition and exchange under varying conditions,

further refining its therapeutic potential.

An

example of these findings is illustrated in the Graphic 2 below, created in collaboration with Smart Assays Biotechnologies Ltd. The

figure depicts the concentration of free iron (Fe2+) in the presence of Telomir-1 (T1) and various ions. When Telomir-1

is introduced, the concentration of free iron decreases (indicated by the shift from the blue point to the orange point). This is

direct evidence for the binding of iron to T1, reducing its free ion concertation in the solution. However, the addition of

copper (Cu2+) at varying concentrations leads to an exchange between bound iron and copper, resulting in the release of

previously bound iron and restoration of free iron levels in solution. This is evidenced by an increase in free iron concentration,

corresponding to the amount of copper added. In contrast, zinc does not induce an exchange effect on the binding of iron to

Telomir-1, indicating a lower affinity of Zinc to

Telomir-1.

Graphic

2: Ionic exchange between iron and copper or zinc

Wilson’s

disease

Wilson’s

disease is a rare genetic disorder affecting approximately 1 in 30,000 individuals worldwide. It is caused by mutations in the ATP7B

gene, which disrupt the body’s ability to regulate copper metabolism. This results in toxic copper accumulation, particularly in

the liver and brain, leading to severe complications such as liver failure, neurological damage, and psychiatric disorders. Without treatment,

Wilson’s disease is fatal.

Current

treatments, including chelating agents (e.g., penicillamine and trientine) and zinc therapy, focus on reducing copper levels but have

notable limitations:

These

challenges highlight the urgent need for novel therapies that address the root cause of Wilson’s disease while minimizing adverse

effects. Telomir-1, with its targeted copper-binding properties, has the potential to provide a safer, more effective treatment by directly

addressing the underlying mechanisms of the disease. Furthermore, Wilson’s disease qualifies as a candidate for orphan drug designation

due to its rarity and life-threatening nature, offering opportunities for accelerated development and additional regulatory and financial

incentives.

We

are actively investigating Telomir-1’s potential in treating Wilson’s disease by studying its effects on copper toxicity

through in vitro experiments and a mouse model of the disease. These studies are currently ongoing.

Type

2 Diabetic (NIDDM)

In

collaboration with the India-based research organization Pentagrit, in 2024 Telomir conducted preclinical studies evaluating two

forms of Telomir-1, administered orally at three different doses, in zebrafish models of Type 2 diabetes mellitus induced by a

high-calorie diet. The study assessed key metabolic indicators, including fasting glucose levels, Oral Glucose Tolerance Test (OGTT)

results, insulin concentrations, and HOMA-IR. The findings revealed:

A

Novel Mechanism of Action

Telomir-1

introduces a novel mechanism of action by addressing the cellular role of iron metabolism in chronic diseases such as Type 2 diabetes.

Excess iron contributes to oxidative stress, beta-cell damage, and insulin resistance. Telomir-1 is designed to normalize iron homeostasis,

reducing oxidative stress and enhancing insulin sensitivity. This differentiates it from current diabetes drugs that primarily treat

symptoms without targeting the underlying causes.

The

study demonstrated significant reductions in fasting plasma glucose to basal levels, improvements in glucose tolerance, and a reversal

of insulin resistance to near pre-diabetic levels. These results were accompanied by improved HOMA-IR values, a standard measure of insulin

sensitivity and resistance, and increased survival rates in treated models.

Global

Impact of Type 2 Diabetes

According

to the International Diabetes Federation, over 800 million adults worldwide are affected by Type 2 diabetes (both diagnosed and undiagnosed),

with annual healthcare costs exceeding $966 billion as of 2021. Existing treatments primarily manage blood glucose and symptoms but fail

to address the root causes of the disease. These therapies are often associated with significant limitations, including minimal impact

on insulin resistance, gastrointestinal issues, risk of hypoglycemia, cardiovascular risks, and weight gain.

The

findings from this zebrafish diabetes model suggest that Telomir-1 could offer a transformative approach to managing Type 2 diabetes.

By targeting the underlying mechanisms of insulin resistance and oxidative stress through iron metabolism normalization, Telomir-1 represents

a potential breakthrough in diabetes treatment. A key indicator of its success was the significant reduction in HOMA-IR values, highlighting

its ability to improve insulin sensitivity and glucose regulation. The reversal of insulin resistance to near pre-diabetic levels underscores

Telomir-1’s potential as a groundbreaking therapy (Graphic).

Graphic

3: Effects of two forms of Telomir-1 on HOMA-IR, a measure of insulin resistance in Zebrafish

We

are currently evaluating the potential in NIDDM by studying the effect of Telomir-1 on several metabolic parameters in a rat model of

NIDDM. These studies are ongoing.

Age

reversal

We

have carried out a preclinical study, conducted in collaboration with Nagi Bioscience SA, utilized a sophisticated in vivo microfluidic-based

assay to assess the effects of Telomir-1 on the nematode Caenorhabditis elegans, a well-established model for aging studies. The microfluidic

platform allowed precise, automated tracking of lifespan, health span, and age-related mobility decline in real-time, enabling the research

team to accurately measure the effects of Telomir-1 on these critical metrics.

Two

forms of Telomir-1 were administered in two concentrations, allowing the study to examine dose-dependent responses in treated subjects.

The study found that Telomir-1 significantly enhanced lifespan and health span parameters in aged microorganism populations. Key findings

included:

Graphic

4: Effect of Telomir-1 on c.elegans life span

Graphic

5: Effect of two forms of Telomir-1 on several motility parameters

Progeria

Study: Telomir-1 Shows Promising Age-Reversal Effects

We

recently completed a study evaluating the effects of Telomir-1 in a nematode model of Progeria (Caenorhabditis elegans). The study

focused on nematodes with a mutation in the wrn-1 gene, the equivalent of the human WRN gene, which is implicated in Werner Syndrome,

a form of Progeria. In C. elegans, wrn-1 depletion is associated with a significantly reduced mean and median lifespan compared to normal

(wild-type) organisms.

The

study demonstrated significant age-reversal effects in wrn-1-mutated nematodes treated with Telomir-1. Treatment effectively restored

longevity levels to those comparable to wild-type organisms. Additional benefits included an extended healthy lifespan and normalization

of physiological parameters such as movement velocity and tail amplitude.

Further

studies in a Progeria human cell line are planned in collaboration with Smart Assays to build on these promising findings.

Oxidative

Stress Study: Telomir-1 Shows potential to Fully Reverse Oxidative Stress and Provide Robust Cellular Protection

Oxidative

stress is a key driver of aging and disease progression, contributing to conditions such as Alzheimer’s, Age-related Macular Degeneration

(AMD), cardiovascular diseases, cancer, and diabetes. It also plays a critical role in the severity of viral infections, including avian

influenza (bird flu), by increasing inflammation, cellular damage, and impairing immune responses. Addressing oxidative stress is essential

for mitigating these effects and improving patient outcomes.

Telomir

Pharmaceuticals recently conducted preclinical studies in collaboration with Smart Assays Biotechnologies Ltd. to evaluate Telomir-1’s

ability to combat copper-induced oxidative stress. The study, performed in human cell lines, demonstrated:

These

findings suggest Telomir-1’s potential to preserve cellular integrity, combat oxidative damage, and regulate metal ion balance—critical

factors in aging-related diseases and viral infections. This breakthrough supports further clinical development to assess its full potential

in disease intervention.

Graphic 6: Effect of Telomir-1 on Oxidative Stress

Graphic 7: Effect of Telomir-1 on Copper Toxicity

Expanding

Telomir-1’s Therapeutic Potential

Building

on these results, Telomir is planning and advancing studies to expand the therapeutic potential of Telomir-1. Key ongoing initiatives

include:

● Cancer Research: Exploring anti-cancer applications using xenograft studies.

Future

Plans and Milestones

Telomir-1

has demonstrated significant potential in reversing age-related and metabolic conditions while targeting underlying disease mechanisms.

As the company continues to refine the molecular understanding of Telomir-1, efforts are underway to identify the most impactful indication

for its initial IND application.

The

company is optimizing manufacturing processes to produce GMP-grade Telomir-1 for IND-enabling studies and future clinical trials. Safety

studies are scheduled for Q2 2025, with IND submission targeted for Q4 2025 and first-in-human trials anticipated in early 2026. Concurrently,

the company aims to secure an INAD to enable veterinary applications, highlighting Telomir-1’s dual potential for both human and

animal health.

Through

these initiatives, Telomir is committed to revolutionizing treatments for age-related and chronic diseases by addressing their root causes

and paving the way for transformative healthcare solutions.

Market

Potential

The

market potential for Telomir-1 is substantial, given its focus on addressing the root causes of age-related diseases and promoting longevity.

Chronic diseases such as diabetes, cancer, Alzheimer’s, and cardiovascular disorders, which are closely tied to aging, account

for over 75% of healthcare spending in the United States, exceeding $4 trillion annually, according to the CDC. As the global population

ages, the demand for innovative therapies targeting the underlying mechanisms of these conditions is expected to grow significantly.

Furthermore, Verified Market Research reports that the anti-aging drug market was valued at approximately $91.05 billion in 2024 and

is projected to reach $160.24 billion by 2031, growing at a compound annual growth rate (CAGR) of 7.32%. With its novel mechanism of

action that regulates cellular metal imbalances and reduces oxidative stress, Telomir-1 is uniquely positioned to capitalize on these

expanding markets, offering transformative potential to enhance health span, slow disease progression, and redefine longevity treatments.

Pre-Clinical

IND-Enabling Studies

As

outlined in the table below, we have successfully completed several IND-enabling studies for Telomir-1, demonstrating its non-toxic profile.

In collaboration with Frontage Laboratories, our research has also established the metabolism and maximum tolerated dose (MTD) of Telomir-1,

providing critical data to support its development.

Type of Study Species Purpose Results

All

preclinical studies referenced in this Annual Report were conducted in collaboration with third-party organizations, including

Frontage Laboratories, InSilico Trials, Pharmaseed Ltd, Smart Assay Biotechnologies Ltd., Recipharm, Naji Biosciences, and Pantagrit. These partners

played a key role in supporting the execution and analysis of the research.

Our

Clinical Development Plan

Upon

completing toxicology studies and preclinical proof-of-concept studies, we plan to submit an Investigational New Drug (IND) application

to the FDA for Telomir-1. While the specific indication is still being evaluated, we intend to explore additional indications with FDA

guidance as the development program evolves. Our first IND submission for Telomir-1 is targeted for the fourth quarter of 2025. If approved

by the FDA, we plan to initiate a Phase I double-blind, randomized, placebo-controlled trial approximately 30 days post-submission. This

trial will assess the safety, tolerability, and pharmacokinetics of Telomir-1 in 40–60 healthy adult male and female participants.

The

progress of our clinical development program will depend on FDA acceptance of our IND submissions. As discussions with the FDA progress,

we may adjust timelines for filings and associated clinical trials when necessary. It is important to acknowledge that conducting clinical

trials is inherently uncertain, and there can be no assurance that our clinical development activities will proceed according to the

planned timelines outlined above.

Manufacture

of Product for Clinical Development Activities

Anthem

Biosciences, a leading contract development and manufacturing organization, initially developed the large-scale synthesis protocol for

Telomir-1, enabling the production of material required for preclinical studies. The manufacturing and synthesis processes have since

been successfully transferred to Recipharm, a globally recognized CDMO known for its expertise in advanced chemistry, operational excellence,

and commitment to delivering high-quality manufacturing solutions.

Market

Opportunity

Telomir-1

is under investigation for its therapeutic potential across multiple areas, including Progeria, Type 2 Diabetes, Wilson’s

disease, Age-related Macular Degeneration (AMD), Alzheimer’s disease, cancer, and other age-related conditions. Additionally,

Telomir-1 is being explored for its potential in mitigating the severity of viral infections such as avian influenza (bird flu) by

addressing oxidative stress and immune dysfunction. These indications are being carefully evaluated to identify the most impactful

opportunities for clinical development and market entry.

The

market potential for these conditions is substantial across the United States, Canada, and Mexico. The Type 2 Diabetes market in the

U.S. alone was valued at approximately $30.47 billion in 2022, according to Fortune Business Insights, driven by rising prevalence and demand

for advanced therapies. The global AMD market is projected to reach $18 billion by 2030, growing at a CAGR of 8.2% from 2024 to 2030.

Alzheimer’s disease, one of the most pressing age-related conditions, is projected to grow significantly, with the global market

expected to reach $13 billion by 2031, according to Allied Market Research, fueled by increasing diagnoses and advancements in treatments

targeting cognitive decline.

The U.S oncology market,

covering a broad range of cancers, was valued at $74.1 billion in 2023, and is projected to reach $180.12 billion by 2033, growing at

a CAGR of 9.2% from 2024 to 2033, as per Precedence Research. Meanwhile, the anti-aging and age-reversal market was valued at $91.05

billion in 2024 globally and is projected to grow to $160.24 billion globally by 2031, with a CAGR of 7.32%, according to Verified Market

Research.

Rare

diseases such as Progeria and Wilson’s disease, despite having smaller patient populations, represent highly lucrative

opportunities due to significant unmet medical needs and strong pricing potential. For instance, the annual treatment cost for

Progeria exceeds $1 million, based on the price of Zokinvy (lonafarnib), the FDA-approved drug for the condition. Similarly,

treatments for Wilson’s disease, like Syprine (trientine hydrochloride), can cost approximately $300,000 per

year.

The global antiviral drugs market is experiencing

significant growth, driven by the increasing prevalence of viral infections and advancements in treatment options. In 2022, the market

was valued at approximately $49.8 billion and is projected to reach around $71.1 billion by 2032, reflecting a compound annual growth

rate (CAGR) of 3.73% during this period.

Specifically focusing on avian influenza (bird

flu), the treatment market was estimated at $22.06 billion in 2023 and is expected to grow at a CAGR of 8.18%, reaching approximately

$38.27 billion by 2030.

These figures highlight the substantial market opportunity for innovative

treatments addressing chronic, age-related, and viral diseases. With increasing demand for therapies targeting oxidative stress, cellular

degeneration, and immune resilience, Telomir-1 is well-positioned to address these critical unmet medical needs. Its broad therapeutic

potential, spanning rare diseases, metabolic disorders, neurodegeneration, and viral infections, represents a significant market opportunity

across North America and beyond, reinforcing its potential as a transformative solution in modern medicine.

Intellectual

Property

We

license the U.S. patent rights for the use of Telomir-1 in human applications from MIRALOGX, LLC (“MIRALOGX”), an intellectual

property development and holding company. MIRALOGX has filed a Patent Cooperation Treaty (PCT) application, PCT/US2023/073106 on

August 29, 2023. The application designated the U.S. and will enter U.S. national phase. The application, if granted and subject to payment

of patent maintenance fees, would offer protection extending through at least August 29, 2043 in the U.S. The patent rights for Telomir-1

outside of the United States are not included in our current patent rights.

Our

license from MIRALOGX is set forth in an Amended and Restated Exclusive License Agreement, dated August 11, 2023, between us and MIRALOGX,

pursuant to which we obtained the exclusive perpetual right and license under the above-described patent rights to make, have made, use,

and sell “Licensed Products” in the U.S. for human uses and pre-clinical studies and activities of any kind conducted in

furtherance of obtaining regulatory approval or commercialization for human uses (the “Initial MIRALOGX License Agreement”).

On November 10, 2023, we and MIRALOGX entered into the Amendment No. 1 to the Amended and Restated License Agreement, pursuant to which

the field of use relating to the license was amended to include therapeutic treatments and other medical or health uses in animals, in

addition to humans, and related preclinical studies and activities conducted in furtherance of obtaining regulatory approval for and

commercialization of veterinary, in addition to human, therapeutic treatments and uses (together with the “Initial MIRALOGX License

Agreement, the “MIRALOGX License Agreement”). “Licensed Product” is defined in the agreement as a drug product

containing as an active agent 2,4,6-tris(3,4-dihydro-2H-pyrrol-2-yl) pyridine or a pharmaceutically acceptable salt, ester, or solvate

thereof. We also have the right to grant corresponding sublicenses under the licensed patent rights. The MIRALOGX License Agreement provides

for the payment to MIRALOGX of an 8% royalty (payable quarterly) on our net sales of Licensed Products by us or our sublicensees and

on non-royalty bearing milestone revenue. There are no up-front, execution, or milestone payments in the license agreement. Further,

no payments have been made to date under the agreement.

Government

Regulation

The

FDA and comparable regulatory authorities in state and local jurisdictions impose substantial and burdensome requirements upon companies

involved in the clinical development, manufacture, marketing, and distribution of drugs. These agencies and other federal, state, and

local entities regulate, among other things, the research and development, testing, manufacture, quality control, safety, effectiveness,

labeling, storage, record keeping, approval, advertising and promotion, distribution, post-approval monitoring and reporting, sampling

and export and import of our drug candidates.

In

the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or FDCA, and its implementing regulations.

The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes

and regulations requires the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements

at any time during the product development process, approval process or after approval, may subject an applicant to a variety of administrative

or judicial sanctions, such as the FDA’s refusal to approve pending New Drug Applications (NDAs), withdrawal of an approval, imposition

of a clinical hold, issuance of warning letters, product recalls, product seizures, total or partial suspension of production or distribution,

injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties. The process required

by the FDA before a drug may be marketed in the United States generally involves the following:

● submission to the FDA of an NDA;

● satisfactory completion of an FDA advisory committee review, if applicable;

Pre-clinical

studies

Before

testing any drug or biological product candidate in humans, the product candidate must undergo rigorous pre-clinical testing. The pre-clinical

developmental stage generally involves laboratory evaluations of drug chemistry, formulation, and stability, as well as studies to evaluate

toxicity in animals, to assess the potential for adverse events (“AEs”) and, in some cases, to establish a rationale for

therapeutic use. The conduct of pre-clinical studies is subject to federal regulations and requirements, including GLP regulations for

safety/toxicology studies. An IND sponsor must submit the results of the pre-clinical studies, together with manufacturing information,

analytical data, any available clinical data or literature and a proposed clinical protocol, to the FDA as part of the IND.

An

IND is a request for authorization from the FDA to ship an investigation product and then administer it to humans and must be allowed

to proceed by the FDA before human clinical trials may begin. Some long-term pre-clinical testing, such as animal tests of reproductive

AEs and carcinogenicity, may continue after the IND is submitted. An IND automatically becomes effective 30 days after receipt by the

FDA, unless the FDA raises concerns or questions before that time related to one or more proposed clinical trials and places the trial

on clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin.

As a result, submission of an IND may not result in the FDA allowing clinical trials to commence.

Clinical

trials

The

clinical stage of development involves the administration of the investigational product to healthy volunteers or patients under the

supervision of qualified investigators, generally physicians not employed by, or under control of, the trial sponsor, in accordance with

GCPs, which include the requirement that all research patients provide their informed consent for their participation in any clinical

trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures,

subject selection and exclusion criteria and the parameters to be used to monitor subject safety and assess efficacy. Each protocol,

and any subsequent amendments to the protocol, must be submitted to the FDA as part of the IND. Furthermore, each clinical trial must

be reviewed and approved by an IRB for each institution at which the clinical trial will be conducted to ensure that the risks to individuals

participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the

informed consent form that must be provided to each clinical trial subject or his or her legal representative and must monitor the clinical

trial until completed. There also are requirements governing the reporting of ongoing clinical trials and completed clinical trial results

to public registries. Information about most clinical trials must be submitted within specific timeframes for publication on the www.clinicaltrials.gov

website. Information related to the product, patient population, phase of investigation, study sites and investigators and other aspects

of the clinical trial is made public as part of the registration of the clinical trial. Sponsors are also obligated to disclose the results

of their clinical trials after completion. Disclosure of the results of these trials can be delayed in some cases for up to two years

after the date of completion of the trial. Competitors may use this publicly available information to gain knowledge regarding the progress

of development programs. Human clinical trials are typically conducted in three sequential phases, which may overlap or be combined.

Post-approval

trials, sometimes referred to as Phase IV clinical trials, may be conducted after initial marketing approval. These trials are used to

gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow

up. In certain instances, the FDA may mandate the performance of Phase IV clinical trials as a condition of approval of an NDA or a Biologics

License Application (“BLA”).

Progress

reports detailing the results of the clinical trials must be submitted at least annually to the FDA and more frequently if significant

adverse events (“SAEs”) occur. The FDA or the sponsor may suspend or terminate a clinical trial at any time, or the FDA may

impose other sanctions on various grounds, including a finding that the research patients are being exposed to an unacceptable health

risk. Similarly, an IRB can refuse, suspend, or terminate approval of a clinical trial at its institution if the clinical trial is not

being conducted in accordance with the IRB’s requirements or if the drug has been associated with unexpected serious harm to patients.

Concurrently

with clinical trials, companies usually complete additional pre-clinical studies and must also develop additional information about the

physical characteristics of the drug or biological product as well as finalize a process for manufacturing the product in commercial

quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches

of the product candidate and, among other things, the sponsor must develop methods for testing the identity, strength, quality, potency,

and purity of the final biological product. Additionally, appropriate packaging must be selected and tested, and stability studies must

be conducted to demonstrate that the biological product candidate does not undergo unacceptable deterioration over its shelf life.

Marketing

Approval

Assuming

successful completion of the required clinical testing, the results of the pre-clinical studies and clinical trials, together with detailed

information relating to the product’s chemistry, manufacture, controls, and proposed labeling, are submitted

to the FDA as part of an NDA requesting approval to market the product for one or more indications. In most cases, the submission of

an NDA is subject to a substantial application user fee.

The

review process typically takes twelve months from the date the NDA is submitted to the FDA. The FDA conducts a preliminary review of

all NDAs within the first 60 days after submission to determine whether they are sufficiently complete to permit substantive review before

accepting them for “filing.” The FDA may request additional information rather than accept an NDA for filing. In this event,

the application must be resubmitted with the additional information and may be subject to an additional application user fee. The resubmitted

application is also subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins

an in-depth substantive review. The FDA reviews an NDA to determine, among other things, whether the drug is safe and effective and whether

the facility in which it is manufactured, processed, packaged, or held meets standards designed to assure the product’s continued

safety, quality and purity. Under the current guidelines in effect in the Prescription Drug User Fee Act (PDUFA), the FDA has a goal

to review and act on the submission within ten months from the completion of the preliminary review of a standard NDA for a new molecular

entity.

The

FDA also may require submission of a REMS plan to ensure that the benefits of the drug outweigh its risks. The REMS plan could include

medication guides, physician communication plans, assessment plans, and/or elements to assure safe use, such as restricted distribution

methods, patient registries, or other risk minimization tools.

The

FDA may refer to an application for a novel drug to an advisory committee. An advisory committee is a panel of independent experts, including

clinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application should be

approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations

carefully when making decisions.

Before

approving an NDA, the FDA typically will inspect the facility or facilities where the product is manufactured. The FDA will not approve

an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate

to ensure the consistent production of the product within required specifications. Additionally, before approving an NDA, the FDA may

inspect one or more clinical trial sites to assure compliance with GCP requirements.

After

evaluating the NDA and all related information, including the advisory committee recommendation, if any, and inspection reports regarding

the manufacturing facilities and clinical trial sites, the FDA may issue an approval letter, or, in some cases, a complete response letter.

A complete response letter generally contains a statement of specific conditions that must be met in order to secure final approval of

the NDA and may require additional clinical trials or pre-clinical studies in order for FDA to reconsider the application. Even with

submission of this additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria

for approval. If and when those conditions have been met to the FDA’s satisfaction, the FDA will typically issue an approval letter.

An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications.

Post-approval

requirements

Drugs

manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among

other things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution, advertising and promotion

and reporting of adverse experiences with the product. After approval, most changes to the approved product, such as adding new indications

or other labeling claims are subject to prior FDA review and approval. There also are continuing annual user fee requirements for any

marketed products and the establishments at which such products are manufactured, as well as new application fees for supplemental applications

with clinical data.

Employees

and Human Capital Resources

As

of February 4th, 2025, we had 5 part-time employees None of our employees is represented by a labor union or are covered

by a collective bargaining agreement. We consider our relationship with our employees to be satisfactory. In addition, we utilize the

services of contractors and part-time outside consultants to support our organization’s needs. We expect to continue to build our

team to ensure we can effectively execute our development plans.

Legal

Proceedings

There

are no material proceedings to which any director or officer, or any associate of any such director or officer, is a party that is adverse

to us or any of our subsidiaries or has a material interest adverse to us or any of our subsidiaries. No director or executive officer

has been a director or executive officer of any business which has filed a bankruptcy petition or had a bankruptcy petition filed against

it during the past ten years. No current director or executive officer has been convicted of a criminal offense or is the subject of

a pending criminal proceeding during the past ten years. No current director or executive officer has been the subject of any order,

judgment or decree of any court permanently or temporarily enjoining, barring, suspending or otherwise limiting his involvement in any

type of business, securities or banking activities during the past ten years. No current director or officer has been found by a court

to have violated a federal or state securities or commodities law during the past ten years. From time to time, we may be named in claims

arising in the ordinary course of business.

We

anticipate that we will expend significant financial and managerial resources in the defense of our intellectual property rights in the

future if we believe that our rights have been violated. We also anticipate that we will expend significant financial and managerial

resources to defend against claims that our products and services infringe upon the intellectual property rights of third parties.

Corporation

Information

We